TYTEK MEDICAL INC.

Address:4700 Ashwood Dr Ste 445,Cincinnati,OH,45241,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bandage, Elastic (FQM) (3) Needle, Aspiration And Injection, Disposable (GAA) (3) First Aid Kit Without Drug (OHO) (2) Catheters, Suction, Tracheobronchial (BSY) (1) Gauze / Sponge,Nonresorbable For External Use (NAB) (1)

Premarket Exempt

Yes

Clear

TPAK - 00855204008006 Catalog Number : TM-303

Device Description : Tension Pneumothorax Decompression Needle: 14 gauge x 3.25"

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

TVAC - 00855204008013 Catalog Number : TM-909

Device Description : Disposable portable suction unit

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : BSY

Prescription Use : No

Device Count : 1

Ptensys Bleeding Control Station - 00855204008020 Catalog Number : TM-400

Device Description : Ptensys Bleeding Control Station

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : OHO

Prescription Use : No

Device Count : 1

Ptensys Bleeding Control Kits - 00855204008037 Catalog Number : TM-401

Device Description : Ptensys Bleeding Control Kits

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : OHO

Prescription Use : No

Device Count : 1

TPAK - 00855204008051 Catalog Number : TM-310

Device Description : Tension Pneumothorax Decompression Needle: 10 gauge x 3.25"

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

TYTEK TRAUMA BANDAGE - 00855204008068 Catalog Number : TM-204

Device Description : 4" Trauma Bandage

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

TYTEK TRAUMA BANDAGE - 00855204008075 Catalog Number : TM-206

Device Description : 6" Trauma Bandage

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

TYTEK TRAUMA BANDAGE - 00855204008082 Catalog Number : TM-212

Device Description : Abdominal Trauma Bandage

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : FQM

Prescription Use : No

Device Count : 1

EZ GAUZE - 00855204008099 Catalog Number : TM-215

Device Description : EZ Gauze - gauze /sponge, nonresorbable for external use

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 1

PneumoDart - 00855204008167 Catalog Number : TM-317

Device Description : Superior Tension Pneumothorax Decompression Needle

Device Class : 1

Duns Number: 078589992

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

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